RecruitingNCT04073420

Medtronic Cardiac Surgery PMCF Registry

Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry


Sponsor

Medtronic Cardiac Surgery

Enrollment

2,700 participants

Start Date

Dec 2, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

This registry is being conducted to support ongoing post-market surveillance activities.


Eligibility

Inclusion Criteria3

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive or be treated with an eligible product
  • Patient is within enrollment window of treatment/therapy received at the time of their initial Registry enrollment, or meets criteria for retrospective enrollment

Exclusion Criteria3

  • Patient who is, or is expected to be, inaccessible for follow-up
  • Patient prohibited from participation by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or device study that may confound results

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Interventions

DEVICESurgical Heart Valve Repair Products

Surgical heart valve repair products.

DEVICESurgical Heart Valve Replacement Products

Surgical heart valve replacement products.


Locations(26)

WellStar Kennestone Hospital

Marietta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

Mount Sinai Medical Center

New York, New York, United States

Saint Francis Hospital

Roslyn, New York, United States

Saint Josephs Hospital Health Center

Syracuse, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University Hospitals Cleveland

Cleveland, Ohio, United States

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Baylor St. Luke's Medical Center

Houston, Texas, United States

The Heart Hospital Plano

Plano, Texas, United States

Inova

Falls Church, Virginia, United States

Allgemeines Krankenhaus - Universitätskliniken Wien

Vienna, Austria

UZ Leuven

Leuven, Belgium

Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, France

Schüchtermann-Klinik

Bad Rothenfelde, Germany

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Albertinen-Herz- und Gefäßzentrum

Hamburg, Germany

Herzzentrum Leipzig

Leipzig, Germany

Deutsches Herzzentrum München Klinik an der TU München

München, Germany

Onassis Cardiac Surgery Center

Athens, Greece

Ospedale Pasquinucci Massa

Massa, Italy

IRCCS Policlinico

San Donato, Italy

Leids Universitair Medisch Centrum

Leiden, Netherlands

Hospital Regional Universitario Carlos Haya Málaga - Hospital General

Málaga, Spain

Inselspital - Universitätsspital Bern

Bern, Switzerland

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NCT04073420


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